March 3, 2014 — GE Healthcare has announced a Class I recall for Giraffe and Panda brand resuscitation systems due to the risk of infant death from over-delivery or under-delivery of oxygen.
The devices provide pulmonary resuscitation for critically ill infants and newborns. They establish a clear airway and provide oxygen or air/oxygen mixtures for ventilation. The Panda Warmer and Giraffe Warmer also regulate body temperature.
Unfortunately, the oxygen and air wall inlet fittings on the back panel of the resuscitation system were reversed during assembly. This could cause too much oxygen or too little oxygen to flow to a critically ill infant, resulting in hypoxia or hyperoxia. These events could be deadly, especially for premature infants.
GE sold nearly 12,400 products from October 2007 through October 2013. They notified customers of the problem with an Urgent Medical Device Correction letter dated November 18, 2013. GE recommends that customers alert care facilities about the recall. For questions or concerns, customers can call GE at 1-800-345-2700, Monday – Friday, 8:00 am – 4:30 pm.
GE Resuscitation System recall includes:
- Giraffe Warmer with Resuscitation System
- Panda Warmer with Resuscitation System
- Giraffe Stand-Alone Infant Resuscitation System
- Resuscitation System Upgrade Kits
- Panda Freestanding with Resuscitation System
The products are also known as:
- Giraffe Warmer
- Panda Warmer
- Panda iRes Warmer
- Giraffe and Panda IRes Infant Warmer
- Giraffe and Panda Bag and Mask Resuscitation System
- Giraffe and Panda Warmer TPiece
- T-Piece Resuscitation System
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